JPRN-jRCT2080220454未知3 期
Phase 3 open-label study of OPC-41061 in subjects with cardiac-induced edema (congestive heart failure) - an investigation of the safety of treatment beyond 7 days and the effect of dose escalation to 30 mg
试验速览
- 阶段
- 3 期
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •1) Subjects receiving one of the following diuretic treatments (including Subjects with cardiac edema receiving diuretic treatments 7 days prior to the start of treatment.
- •2) Subjects receiving one of the following diuretic treatments since 3 days prior to the commencement of study drug administration without changing the dose or dosing regimen (including subjects scheduled to start treatment during the run-in observation period).
- •- A loop diuretic at a daily dosage equivalent to 40 mg or more of furosemide
- •- Concomitant administration of a loop diuretic and a thiazide diuretic (at any doses)
- •- Concomitant administration of a loop diuretic and an anti-aldosterone drug (at any doses)
- •3) CHF patients with lower limb edema, jugular venous distention, or pulmonary congestion due to extracellular volume expansion.
- •4) Male or female subjects between the ages of 20 and 85, inclusive (at time of informed consent)
- •5) Subjects able to stay at the study site from the day before the start of the run-in observation period until completion of post-treatment observation 2 (7 to 10 days after final study drug administration)
- •6) Subjects capable of giving informed consent to participate in the study of their own free will
排除标准
- 未提供
研究者
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